Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device submissions, but the final guidance lends also clarifies a couple of points about when an investigational device exemption will be needed for RWE studies.
The U.S. FDA announced Dec. 15 that it will take a more relaxed approach to device premarket applications using real-world evidence from data sources that lack individual patient-level data, a switch that might ease manufacturers’ efforts to expand a device’s labeled indication for use.
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
Data-driven health care platform company Kakao Healthcare Corp. may be embarking on its most ambitious project yet: launching an effective “AI-platform bridge” over patient waters to connect medical institutions, government and the industry for novel drug discovery and research.
Data-driven health care platform company Kakao Healthcare Corp. may be embarking on its most ambitious project yet: launching an effective “AI-platform bridge” over patient waters to connect medical institutions, government and the industry for novel drug discovery and research.
Real-world evidence (RWE) is all the rage in med-tech circles, given the promised efficiencies, but the U.K. National Institute for Health and Care Excellence is especially dialed in on RWE. The agency recently announced that it will expand its use of RWE to include health technology assessments (HTAs), promising a slightly less drag-filled path to clinical adoption in one of the world’s most robust markets.
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions.
